MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number 83779

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the main coil was kinked and detached at the zap tip section and it was observed stretched and bent at the coil arm section.Under the microscope it was observed that the main coil was kinked and detached at the zap tip section, and it was observed stretched and bent at the coil arm section.The functional inspection could not be performed, because only the main coil was returned.Dimensional inspection revealed that the coil arm and primary coil outer diameter passed the required specification.

Event Description

Reportable based on device analysis completed on 17jul2023.It was reported that the coil could not be pushed out of the microcatheter.The target lesion was located in the splenic artery.A 22mm x 60cm interlock was selected for use for embolization with 18 other coils.During the procedure, the third 22mmx60cm coil was pushed out, after it was advanced half of the non boston scientific microcatheter.However, the resistance became larger and it could not be pushed out.In order to ensure the successful completion of the procedure, a new microcatheter and a new coil of the same model were used to continue the procedure.The device was successfully deployed and the procedure was successfully completed.No complications were reported and the patient was stable post procedure.However, device analysis revealed that the main coil was detached at the zap tip section.

• Brand Name: INTERLOCK
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17482441
• MDR Text Key: 320719198
• Report Number: 2124215-2023-41382
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: 08714729845324
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030244211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 71 KG